Clinical Research Associate II: Global Site Monitoring

BioSpace; Oakville (MO); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Innovative work culture

Professional development

Paid time off

Employee stock purchase

Wellness spending account

Flexible health insurance

Retirement savings programs

Bonus plan

Job summary

AbbVie is seeking a Clinical Site Monitor to proactively address study-related site issues and ensure protocol level execution across start-up, execution, and close-out phases. The role emphasizes regulatory compliance, data integrity, and investigator coordination in US clinical studies.

You will travel to sites (up to 50%), monitor visits, train staff, and support corrective actions while ensuring patient safety and adherence to ICH/GCP guidelines and AbbVie SOPs.

Qualifications

• Appropriate tertiary qualification in health-related field preferred.
• Minimum of 2 years clinically-related monitoring experience.
• Knowledge of therapeutic indications relevant to clinical trials.
• Familiarity with regulatory requirements for clinical research (ICH/GCP, regulations).
• Experience with site monitoring: data, drug accountability, and documentation.

Responsibilities

• Monitor site activities to ensure protocol execution and regulatory compliance.
• Conduct site qualification, initiation, interim monitoring and closeout visits for Phase I–III studies.
• Oversee site personnel activities and ensure corrective actions and compliance.
• Ensure timely data submission and safety reporting for study sites.
• Safeguard subject safety in line with monitoring plans and SOPs.
• Train site personnel on protocol and regulatory requirements.
• Manage investigator payments and site agreements.
• Identify potential investigators/sites to support clinical studies.

Skills

Clinical monitoring experience

Regulatory knowledge

GCP/ICH familiarity

Planning and organization

Interpersonal communication

Travel willingness

Tech savviness

Microsoft Office

Documentation and data management

Budget and payments handling

Education

Health-related degree (Medical, Scientific, Nursing)

Tools

None

Job description

AbbVie is seeking a Clinical Site Monitor to proactively address study-related site issues and ensure protocol level execution across start-up, execution, and close-out phases. The role emphasizes regulatory compliance, data integrity, and investigator coordination in US clinical studies.

You will travel to sites (up to 50%), monitor visits, train staff, and support corrective actions while ensuring patient safety and adherence to ICH/GCP guidelines and AbbVie SOPs.